(77 days)
WIRION™ is indicated for use as an embolic protection system (EPS) to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting in the carotid arteries and atherectomy in calcified lesions of the lower extremities (LE) arteries.
The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.
WIRION™ is a embolic protection system comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator. The WIRION™ is identical to the FDA cleared (K143570) WIRION device indicated for use in carotid artery stenting (CAS) procedures.
The document describes the acceptance criteria and study findings for the WIRION™ Embolic Protection System (EPS).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Study Endpoint: Freedom from Major Adverse Events (MAE) to 30 days post-procedure. Historic controls average MAE rate: 10.6%. Performance Goal (PG) for WIRION™ was not explicitly stated as a numerical value but the study aimed to show superiority/non-inferiority to the historical control. | MAE Rate: 1.9% (2 out of 103 patients). The P-value obtained ( |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).